Work Schedule

10 hr shift/days

Environmental Conditions

Laboratory Setting

Job Description

Scientist I, QC Microbiology

About the Role

The Scientist I, QC Microbiology will support the cGMP-compliant Quality Control Microbiology Laboratory in support of biological product manufacturing and release. This role is responsible for performing routine microbiological testing, supporting validation and qualification activities, reviewing and summarizing laboratory data, and authoring controlled GMP documentation. The successful candidate will collaborate with cross-functional partners to ensure sample flow, testing support, equipment readiness, and supply management are maintained in a compliant and timely manner.

This position supports GMP manufacturing operations and release testing and requires a strong commitment to quality, compliance, and laboratory safety.

What Will You Do?

• Perform microbiological testing in accordance with GMP procedures, including bioburden, bacterial endotoxin, growth promotion, biological indicator, and stock culture testing.
• Support bioburden and endotoxin validation studies.
• Perform qualifications of microbiological methods and media.
• Draft, revise, and technically interpret controlled documents, including SOPs, Test Records, summary reports, and supporting documentation.
• Review testing data; analyze and summarize results with appropriate guidance.
• Initiate and support investigations related to Out of Specification results and laboratory incidents in TrackWise.
• Partner with internal departments to ensure sample flow, testing timelines, supply chain support, and equipment disposition are maintained appropriately.
• Order laboratory supplies and maintain required inventory in accordance with SOPs.
• Coordinate shipment of samples to contract laboratories for microbial identification or additional testing.
• Support sample logging and data reporting in LIMS, as assigned.
• Maintain safe laboratory practices and ensure work is conducted in compliance with site safety and GMP requirements.
• Provide laboratory support for manufacturing activities and release testing.
• Perform other assigned duties as required to support laboratory and business needs.

How Will You Get Here?

Education

• Bachelor’s degree in Life Sciences, Biology, Microbiology, or related scientific field required.
• Degree concentration in Microbiology preferred.

Experience

• Experience in a microbiology, quality control, or regulated laboratory environment preferred.
• Experience supporting GMP or cGMP laboratory operations preferred.
• Familiarity with microbiological testing methods such as bioburden, bacterial endotoxin, growth promotion, and biological indicator testing preferred.
• Experience with quality systems such as TrackWise and laboratory systems such as LIMS is preferred.

Knowledge, Skills, Abilities

• Knowledge of microbiological principles and laboratory techniques.
• Understanding of GMP/cGMP requirements and good documentation practices.
• Ability to write, review, and interpret controlled documents and technical reports.
• Ability to review laboratory data, identify issues, and support investigations.
• Strong attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Ability to work effectively in a cross-functional team environment.
• Ability to manage multiple priorities in a fast-paced, regulated laboratory setting.

Physical Requirements / Working Conditions

• This position is an on-site role in a laboratory environment.
• Standard schedule is Monday through Friday, 8:00 AM to 5:00 PM.
• Flexibility to support overtime, weekends, and holidays may be required based on manufacturing schedules and project timelines.
• May require standing for extended periods, use of laboratory equipment, and handling of laboratory materials in accordance with safety procedures.